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Catumaxomab

Removab

Extended indication Advanced Gastric Cancer with Peritoneal Metastasis
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Catumaxomab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Stomach cancer
Extended indication Advanced Gastric Cancer with Peritoneal Metastasis
Proprietary name Removab
Manufacturer Neovii
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Bispecific antibody. Dit geneesmiddel is eerder teruggetrokken voor de indicatie maligne ascites. Ook door de cieBOM is vastgesteld dat het niet is aangetoond dat catumaxomab een klinisch relevante meerwaarde heeft in de behandeling van patiënten met deze indicatie.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2022
Expected Registration September 2024
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Primary completion datum fase 2 studie in januari 2023.

Therapeutic value

Current treatment options Cytoreductieve chirurgie (CR) en hypertherme intraperitoneale chemotherapie (HIPEC)
Therapeutic value No estimate possible yet
Substantiation Op dit moment lopen de studies nog.
References NCT04222114
Additional remarks The starting dose of catumaxomab for intra-peritoneal infusion will be 10μg, gradually increased to 20μg, 50μg and 150μg, respectively. From the second cycle, catumaxomab will be changed to 20μg,50μg,150μg on days 1,4 and 8.

Expected patient volume per year

Patient volume

110 - 232

Market share is generally not included unless otherwise stated.
References A Rijken. The Burden of Peritoneal Metastases from Gastric Cancer: A Systematic Review on the Incidence, Risk Factors and Surviva. 2021l(1); NKR2021(2);
Additional remarks Peritoneale metastasen (CPM) komen voor in 10 tot 21% van de patiënten die een maagcarcinoom hebben (1). In 2021 waren er 1.109 patiënten met een maagcarcinoom (2).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.